Phase 3 readout sets up filings for Pfizer's meningitis vaccine
Pfizer's close-fought contest with GSK to bring a next-generation meningitis vaccine to market has entered the final rounds, with the former ahead on points following the readout of a pivotal phase 3 clinical trial.
Both companies are developing MenABCWY vaccines that cover all five meningococcal strains in one go as an alternative to separate vaccinations, in the hope of simplifying immunisation schedules and reducing the number of injections needed, as well as potentially enhancing uptake and reducing costs.
Pfizer's MenABCWY shot – which combines its MenACWY vaccine Nimenrix with and MenB jab Trumenba – will now be filed for FDA approval in adolescents and young adults in the fourth quarter of this year, with applications to other regulators also planned.
The phase 3 trial involved 2,431 subjects aged 10 through 25, including those who have and have not received MenACWY vaccines in the past, and compared two doses of Pfizer's new shot to two doses of Trumenba plus one dose of GSK's MenACWY vaccine Menveo. None of them had been previously vaccinated against MenB.
According to Pfizer, the new vaccine was non-inferior to the control group against all five meningococcal strains, while a single dose was as effective as Menveo at protecting against MenACWY.
The company has long argued that the current need to use multiple meningococcal vaccines to provide coverage has resulted in confusion among consumers and doctors, leading to poor compliance and low sales.
A MenABCWY shot would solve the problem and encourage greater uptake, helping to protect young people from invasive meningococcal disease that is rare but can be devastating, in some cases killing people in as little as 24 hours.
Last year, Nimenrix generated $193 million in sales, a decline on the prior year attributed to the pandemic, but recovered with a 50% gain in the first half of this year to $142 million. Pfizer doesn't break out sales of Trumenba.
GSK is anticipating a phase 3 readout for its MenABCWY vaccine this year as well, and has previously said that it thinks the shot could eventually generate $1.1 to $2.2 billion in peak sales.
Its shot is a combination of Menveo and its Bexsero MenB vaccine and is being tested in a 3,650-subject study due to generate results this month, according to its clinicaltrials.gov listing.
GSK is currently the market leader in the meningococcal vaccine category, with the franchise bringing in around $513 million in the first half of this year, with Bexsero contributing around three quarters of that total.
"The potential recommendation of a pentavalent vaccine in the US as an alternative to the existing MenACWY vaccines across both the 11- to 12-year-old and 16-year-old vaccination platforms provides a significant opportunity for Pfizer to enter the US MenACWY vaccine market and help protect more young people across the country," commented Angela Hwang, head of Pfizer's global biopharma business.
"Today, we estimate there are approximately 52 million adolescents and young adults who are in the age range for meningococcal vaccination according to [Centres for Disease Control and Prevention] guidance," she added.